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    A pilot randomised controlled trial of a Telehealth intervention in patients with chronic obstructive pulmonary disease: challenges of clinician-led data collection

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    Publication date
    2014-08-06
    Author
    Bentley, C.L.
    Mountain, Gail
    Thompson, J.
    Fitzsimmons, D.A.
    Lowrie, K.
    Parker, S.G.
    Hawley, M.S.
    Keyword
    Chronic obstructive pulmonary disease; Implementation; Pilot RCT; Telehealth; Telemonitoring
    Rights
    © 2014 Bentley et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
    Peer-Reviewed
    Yes
    
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    Abstract
    Background: The increasing prevalence and associated cost of treating chronic obstructive pulmonary disease (COPD) is unsustainable, and focus is needed on self-management and prevention of hospital admissions. Telehealth monitoring of patients’ vital signs allows clinicians to prioritise their workload and enables patients to take more responsibility for their health. This paper reports the results of a pilot randomised controlled trial (RCT) of Telehealth-supported care within a community-based COPD supported-discharge service. Methods: A two-arm pragmatic pilot RCT was conducted comparing the standard service with a Telehealth-supported service and assessed the potential for progressing into a full RCT. The co-primary outcome measures were the proportion of COPD patients readmitted to hospital and changes in patients’ self-reported quality of life. The objectives were to assess the suitability of the methodology, produce a sample size calculation for a full RCT, and to give an indication of cost-effectiveness for both pathways. Results: Sixty three participants were recruited (n = 31 Standard; n = 32 Telehealth); 15 participants were excluded from analysis due to inadequate data completion or withdrawal from the Telehealth arm. Recruitment was slow with significant gaps in data collection, due predominantly to an unanticipated 60% reduction of staff capacity within the clinical team. The sample size calculation was guided by estimates of clinically important effects and COPD readmission rates derived from the literature. Descriptive analyses showed that the standard service group had a lower proportion of patients with hospital readmissions and a greater increase in self-reported quality of life compared to the Telehealth-supported group. Telehealth was cost-effective only if hospital admissions data were excluded. Conclusions: Slow recruitment rates and service reconfigurations prevented progression to a full RCT. Although there are advantages to conducting an RCT with data collection conducted by a frontline clinical team, in this case, challenges arose when resources within the team were reduced by external events. Gaps in data collection were resolved by recruiting a research nurse. This study reinforces previous findings regarding the difficulty of undertaking evaluation of complex interventions, and provides recommendations for the introduction and evaluation of complex interventions within clinical settings, such as prioritisation of research within the clinical remit.
    URI
    http://hdl.handle.net/10454/11006
    Version
    Published version
    Citation
    Bentley CL, Mountain GA, Thompson J et al (2014) A pilot randomised controlled trial of a Telehealth intervention in patients with chronic obstructive pulmonary disease: challenges of clinician-led data collection. Trials. 15(1): 313.
    Link to publisher’s version
    http://dx.doi.org/10.1186/1745-6215-15-313
    Type
    Article
    Collections
    Health Studies Publications

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